Technology

The Multifunctional CardioGram® (MCG) is unlike any other diagnostic cardiology test. It is a physiologic test, not an imaging or anatomic one. The wide array of its assessments is embodied in the term multifunction in its name. The MCG test acquires its data by setting up two standard electrocardiographic leads to have a “conversation” over several cycles. The “conversation” is a series of signals sent out for exploration by the first lead, followed by a response and signal returned by the second lead, and then followed by a continuous back and forth signal and response exchange between the 2 leads. This exploration is made possible by the application of several steps, namely the conversion of the time domain of the voltage display to a frequency domain; the adaptation of Legrangian mathematics to identify the physiological and physical nature of various components of the dynamic cardiovascular system; and the use of artificial intelligence (AI) in the comparison of these findings with a laboriously built data base.

The MCG Test conducts a physiologic analysis and evaluation of multiple cardiac functions, evaluating strengths and weaknesses at the cellular and subcellular levels. The MCG test is able to detect physiological damage or dysfunction at a far earlier than other modalities. Once it is understood that the MCG test is a physiologic analysis, one should not be surprised that the findings may not yet be confirmed by an echocardiogram, a stress test or CT angiogram because the MCG data uncovers the footprints of pathology long before it is clinically significant enough to be detected with standard diagnostic tools.

The Multifunction CardioGram® (MCG) takes a systems approach to the mathematical models based on the La Grange – Eüler theory to look at the FUNCTION of the heart as opposed to an anatomical picture that the current tools provide. It combines the results using 6 mathematical transformations derived from the fusion of both the La Grange (mathematics of the electrical activity of the human muscle, in this case the heart) and Eüler (mathematics of the electrical activity of the human blood) coordinates via a Laplace Transformation.

The theory behind the MCG systems approach is: the heart will compensate at the molecular level for imbalances in supply and demand for oxygen in the heart muscles. This compensation creates distinct electrical patterns that the MCG finds by using highly advanced mathematical analysis comparing Lead II vs. V5 over an extended period of time (82 seconds).

Once the data is collected from the patient using Digital Signal Processing (DSP) it is transmitted to the “cloud” where the 6 mathematical transformations are performed, creating 168 indices based on the patient’s physiology, they tend to cluster based on their cardiac condition. These 168 indices are then compared to a large empirical patient database of over 200,000 patients, which is equally divided between males and females. The age range is 14 to 104 years old, 30% are clinically normal and 70% have a broad range from mild to very severe cardiac pathologies.

A written diagnostic report is generated in less than two minutes and is available online, in a pdf format through a secure HIPAA compliant website. It reveals whether the patient has local ischemia, global ischemia or both along with 26 pathological and physio-pathological data points which together creates a numerical score that represents the disease burden from 0 – 22, then in to an 8 category diagnosis plan.

The MCG approach has been proven to be both consistently repeatable and highly accurate when compared to coronary angiography through rigorous clinical trials approved and monitored by the FDA. The MCG report provides new information never available before with imaging tests. Additional clinical studies have been performed around the world and show very high sensitivity and specificity compared to coronary angiography and the platinum standard of coronary angiography with FFR, fractional flow reserve (in the 95% range for both sensitivity and specificity when looking for stenosis).

To demonstrate what we have accomplished to thoroughly verify and validate the Multifunction CardioGram® (MCG), most recently, our colleagues from Japan and many other countries have conducted independent meta-analysis of the data of thousands of patients collected over the past five years from multiple centers, and concluded the following in “A Phase Five Post Market Surveillance Data Meta-Analysis Concludes” (pending publication):

The MCG system is:

3 to 5 times more accurate than conventional ECG
2 to 3 times more accurate than echocardiogram
2 to 3 times more accurate than nuclear, echo, ECG, and pharmacological stress tests
Reproducibly “compatible” with the current platinum standard – Coronary Angiography plus Fractional Flow
Reserve, Classical or Functional Syntax Scores with replicable results. However, they also concluded that MCG may be much better in areas that coronary angiography cannot detect, such as small vessel microvascular disease and metabolic heart disease due to type two diabetes.

SOME EXAMPLES OF THE UNIQUE CAPABILITIES OF THE MCG SYSTEM THAT THE PHYSICIAN COMMUNITIES HAVE DISCOVERED OVER THE YEARS ARE:

It can quantify the degrees of functional loss of the myocardium and its interaction with other factors such as blood supply, metabolic disorders (such as diabetes), heart failure of any cause, and many inflammatory, infectious, or neural hormonal systemic disorders, etc.
It can detect low, intermediate, and high degrees of ischemia due to all stages of coronary artery disease, from very early (as little as 30% coronary artery narrowing to 100% occlusion with or without the collaterals).
It is just as accurate for people with low risks as it is for people with intermediate or high risks for CAD. Conventional imaging tools can only detect late-stage disease at poorer accuracies.
It is just as accurate for women as it is men, or people EKG output shows Left, Right, or Simple Bundle Branch Block.
It can detect increased myocardial ischemia due to post-interventional restenosis (the evidence shows MCG is correct 100% of the time). The reverse is also true – the MCG system can directly measure the functional reversal of metabolic heart disease due to Type II Diabetes and/or Coronary Artery Disease.
It can detect recurrent Atrial Fibrillation post ablation procedures, also at 100% of the time.
It can detect “Incipient” Atrial Fibrillation or potentially lethal ventricular arrhythmia BEFORE they are visible by the conventional EKG.
The MCG system’s capability to detect abnormal expressions of the aspect of the myocardial system is beyond the conventional ECG, echo, all stress imaging tests, and coronary angiogram can provide. The possibility of a human predicting sudden cardiac death has become a reality using the MCG system.

The Multifunction CardioGram® takes a systems approach to the mathematical models based on the LaGrange- Euler Differential Equation Theory, describing the physics of the dynamic interactions between the myocardium and the intracardiac blood flow. MCG adopts mathematical transformations in its Digital Signal Processing (DSP functions) algorithms to express the interactions between two resting EKG vectors to extract new information from the whole heart as a system-otherwise not observable in the traditional EKG. MCG measures the interactions or communications between the signals from a pair of left ventricular leads, Lead V5 and Lead II, in both frequency and time domains, making it fundamentally different than the time vs voltage 2-D plots used by conventional EKG.